Anti-reflux valve interconnected with a catheter

[0002] Not Applicable

[0003] Not Applicable

[0004] 1. Field of Invention

[0005] This invention pertains to surgical drains for removal of fluid from a patient. More particularly, this invention pertains to a valve for one-way draining of fluids through a catheter attached to a patient.

[0006] 2. Description of the Related Art

[0007] Prior catheter collection devices have provided conduits for fluid drainage from a body cavity of a patient including tubing and an externally connected valve for unidirectional flow of fluid into a collection receptacle. Typically the catheter is connected by a length of tubing to the externally connected valve that is manipulated by an attendant or the patient to purge the tubing of fluids by channeling flow into a collection receptacle such as a detachable bag. It is imperative to minimize the possibility of reflux to reduce the potential for infection in patients utilizing a urethral drainage catheter or a similar drainage conduit from a patient. A typical valve for a catheter allows for flow past the valve due to an upgradient liquid pressure in the catheter forcing liquid through the valve. Alternatively a shut-off clamp is manipulated by an attendant or the patient to allow drainage of the fluids through a catheter. Upon manipulation of the shut-off clamp, or during operation of the needle valve, there is an opportunity for reflux and passage of infectious materials upstream to the patient.

[0008] There is a need for an anti-reflux valve that forms a one-way drain valve within a catheter for drainage of fluids. A need exists for a discharge valve that may be incorporated with a like configured second discharge valve within a catheter. A further need is for an anti-reflux valve that is a self-contained conduit having at least one inline valve positioned within the conduit for ease of sterilization and for ease of use as a sterile unit that is packaged for rapid access and connection with a drainage catheter during a medical procedure in a sterile environment.

[0009] According to one embodiment of the present invention, an anti-reflux valve is provided for control of flow through a catheter and toward a fluid collection reservoir. The anti-reflux valve includes a check valve positioned within a segment of a catheter, the check valve includes a proximal end that is substantially cylindrical and forms a junction bonded to the interior circumference of the catheter. The check valve includes a side wall that is continuous, composed of pliable material, and is reduced in diameter at a distal end having a circumferential opening that is collapsible upon itself upon the presence of counter-current fluid pressure. One-way flow of liquids from a patient is maintained through the segment of the catheter having the anti-reflux valve therein, with flow permitted through the proximal end of the check valve and through the distal end of the valve toward a tube connection with a fluid collection reservoir. Reverse flow through the distal end of the check valve is not allowed due to the closure of the opening of the distal end upon the presence of counter-current fluid against the pliable material of the distal end. The anti-reflux valve includes at least one check valve, or alternatively two or more check valves aligned in series within the catheter, with the distal end of a first check valve aligned with a proximal end of a second check valve, in a repetitive series of check valves leading toward the tube connection with the fluid collection reservoir. A method of utilization of the anti-reflux valve is also disclosed for use of at least one check valve within a drainage catheter as part of a medical procedure practiced in a sterile environment.

[0010] The above-mentioned features of the invention will become more clearly understood from the following detailed description of the invention read together with the drawings in which:

[0011] FIG. 1 is a side view of an anti-reflux valve of the present invention, positioned within a catheter connected to a collection reservoir;

[0012] FIG. 2ais a perspective view of the anti-reflux valve, illustrating a distal end of a check valve in an open position to allow passage of fluid;

[0013] FIG. 2bis an end view of FIG. 2a, illustrating the distal end of the check valve in an open position;

[0014] FIG. 3ais a perspective view of the anti-reflux valve, illustrating the distal end of the check valve in a collapsed position within the catheter;

[0015] FIG. 3bis an end view of FIG. 3a, illustrating the distal end of the check valve in a collapsed position;

[0016] FIG. 3cis a side view of FIG. 3b, illustrating the stoppage of reflux flow of discharge liquids by the collapsed distal end of the check valve;

[0017] FIG. 4 is a perspective view of two check valves aligned in series with an open first valve having flow therethrough, and a second valve collapsed due to the pressure of reflux fluid from a collection reservoir; and

[0018] FIG. 5 is a perspective view of an anti-reflux valve system of the present invention including a plurality of check valves aligned in series within a segment of a catheter.

[0019] An anti-reflux valve 10 is disclosed for connection within a tube such as a catheter for one-way passage of fluids from a patient for delivery to a fluid collection reservoir as illustrated in FIG. 1. The anti-reflux valve 10 provides protection from infection and contamination of a patient's internal body fluids due to potential exposure to external fluids refluxed from a collection reservoir. The anti-reflux valve 10 includes a catheter 12 having a first end 14 adapted to be inserted into a patient, and having a second end 18 adapted to be releasably attached to a collection reservoir 82. The walls 20 of the catheter are of a thickness applicable to the use associated with insertion into the patient.

[0020] A check valve 30 is adapted to be received within the catheter 12, with the check valve 30 including a proximal end 32 having a perimeter 34 bonded to an inside periphery of an interior surface 16 of the catheter 12. The proximal end 32 is oriented toward the first end 14 of the catheter 12, and therefore is oriented toward the patient. The proximal end 32 remains in a substantially open configuration 36 for passage of fluids therethrough (see FIGS. 1 and 2a). The check valve 30 includes a length of flexible material that forms continuous side walls 38 that are pliable in a length dimension (see FIGS. 2aand 3a). The side walls 38 of flexible material form continuous surfaces that channel discharge fluids to a distal end 40 of the check valve 30. The flexible material of the side walls 38 can include material that is known to those skilled in the art to allow sterilization while maintaining pliability of the flexible material. The distal end 40 is oriented toward the catheter second end 18 that is releasably connected to a collection reservoir 82. The distal end 40 of the check valve 30 may remain in a partially open 42 configuration as discharge fluids 80 drain in a preferred direction 22 through the proximal end 32 and the distal end 40, and toward the catheter second end 18 and into the collection reservoir 82.

[0021] The distal end 40 is preferably biased to a closed configuration 48 (see FIG. 3b) after discharge of fluids therethrough, with the distal end 40 remaining collapsible upon itself when any significant amount of refluxed fluid applies back pressure against the distal end 40 (see FIG. 3c). The distal end 40 includes a flexible perimeter edge 46 formed by the distal ends of the length of flexible material 38. The orientation of the check valve 30 within the catheter 12 allows flow of fluids from the catheter first end 14, through the valve proximal end 32, through the valve distal end 40, and to the catheter second end 18. The valve distal end 40 stops reflux of fluids after discharge from the valve distal end 40 due to the closure of the flexible perimeter edge 46 of the distal end 40 to a collapsed position 48.

[0022] One embodiment of the anti-reflux valve 10 includes at least one check valve 30 positioned within an interior section of a catheter 12 (see FIGS. 1, 2a, 2b, 3a, and 3b). An alternative embodiment of the anti-reflux valve 10 includes two check valves 30, 60 aligned in series within an interior section of a catheter 12 (see FIG. 4). The distal end 40 of the first check valve 30 is aligned with a proximal end 62 of a second check valve 60, with a distal end 70 of the second check valve 60 oriented toward the catheter second end 18 and the collection reservoir 82. The second check valve proximal end 62 includes a perimeter 66 bonded to an inside periphery of the interior surface 16 of the catheter 12. The proximal end 62 remains substantially open for passage of fluids therethrough that pass through first check valve distal end 40. A distal end 70 of the second check valve 60 is biased to a closed configuration after discharge therethrough of fluids, with the second valve distal end 70 oriented toward the catheter second end 18. A length of flexible material 68 forms continuous walls of the second check valve 60, with the length of flexible material 68 being pliable in a length dimension. An additional alternative embodiment of the anti-reflux valve 10 includes a series of a plurality of check valves aligned within a catheter 12 (see FIG. 5). The plurality of check valves includes a first check valve 30 shown in an open position 36, a second check valve 60 shown in a partially closed position 42, and a third check valve 78 shown in a collapsed position 48. A plurality of check valves provides increased success in stoppage of reflux of discharge liquids 80, thereby reducing the risk of infection from exposure of discharge fluids 80 to the patient during long-term use of a plurality of anti-reflux valves 10 of the present invention.

[0023] A method of utilization of the anti-reflux valve is also disclosed for use of one or more check valves 30, 60 within a catheter 12 providing drainage of fluids from a patient as part of a medical procedure practiced in a sterile environment. The method includes providing a sterilized segment of a catheter 12 having at least one check valve 30 therein. The sterilized catheter segment is removably connected between a catheter implanted in a patient, and a tube leading to a collection reservoir 82. The method of utilization includes inspecting the sterilized catheter segment having at least one check valve therein for continuous one-way flow of fluids from the patient. Periodically, a detaching step occurs with the sterilized catheter segment detached from the catheter implanted in a patient, with replacement with a like configured sterilized catheter segment having at least one check valve 30 therein. Therefore, a detachable catheter segment is provided having at least one check valve 30 that is easily disconnectable and replaced with a like configured catheter segment having one check valve 30 therein, or replaced with a like configured catheter segment having at least two check valves 30, 60 therein, while maintaining sterile conditions within portion of the catheter upgradient of the anti-reflux valve 10 of the present invention.

[0024] From the foregoing description, it will be recognized by those skilled in the art that an anti-reflux valve is disclosed including a check valve adapted to be received within a catheter. The anti-reflux valve may include an alternative embodiment having two check valves interdisposed in series in an aligned orientation within a catheter. The anti-reflux valve may further include an alternative embodiment having a plurality of check valves interdisposed in series in an aligned orientation within a catheter to minimize the potential of reverse flow of fluids after being discharged from the most distal end of the series of check valves. Further, a means for disconnection may be included at opposed end of a segment of catheter having one or more check valves interdisposed therein to allow rapid replacement of a sterile segment of a catheter having check valves interdisposed therein when catheter tubing is replaced for a patient, thereby minimizing the possibility of infection of the patient due to the reflux of non-sterile bodily fluids.

[0025] While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of applicants' general inventive concept.